Confidentiality broken? It's a costly lesson
Confidentiality broken? It’s a costly lesson
What happens when QA documents get leaked?
One of the nation’s busiest heart transplant centers is under intense scrutiny from the Joint Commission on Accreditation of Healthcare Organizations in Oakbrook Terrace, IL, after internal quality assurance documents were leaked to a national newspaper. The white-hot spotlight on Rush Presbyterian-St. Luke’s Medical Center in Chicago shows how your internal efforts to improve quality of care can backfire if they land in the wrong hands.
The intensive review of clinical standards at Rush raises difficult questions about the confidentiality of quality assurance documents and about dangers that can accompany boosting the numbers. National media attention resulting from a breach of security of quality assurance (QA) documents also puts the spotlight on how the media covers perceived quality problems and the appropriate function of the Joint Commission.
On Dec. 10, 1996, Rush was approved for Medicare payments of heart transplants. Two days later, The Wall Street Journal accorded front-page status to the hospital and accused the facility’s heart transplant team of "unwise procedures" and questioned the quality of patient care before and after surgery. Hospital officials defended their facility and have announced plans to file a defamation suit against the newspaper. In an open letter to physicians, friends, and employees of the medical center, Leo M. Henikoff, MD, president and CEO of Rush, cited a number of inaccuracies in the article.
Days after the media coverage, the Joint Commission’s vice president for accreditation services and his senior staff determined a sentinel event had taken place at Rush. Henikoff was told on Dec. 18, 1996, that a physician surveyor was coming to review what happened. Based on the surveyor’s findings, the Joint Commission subsequently found the transplant program to be in full compliance with Medicaid quality standards.
Internal QA document cited
In a Dec. 16 letter to the editor of The Wall Street Journal, Henikoff points out the source for much of the published article was a draft internal quality assurance review document from Rush. "In the quality assurance processes, physicians are encouraged to be highly critical of themselves and their colleagues in order to advance patient care," the letter explains. "To ensure complete candor, the utmost confidentiality is accorded such documents. Often initial impressions are revised as a result of a comprehensive review of all relevant data. It is a crime in Illinois to disclose such quality assurance documents. This unprecedented action of The Wall Street Journal is not only reckless but undermines the very process of quality assurance that is so vital to the public interest."
The letter continues, "In heart failure patients, the proper therapeutic approach is keenly debated by physicians because there is no right answer as to the proper balance between conservative and aggressive therapies. The use of hyperbolic statements based on quality assurance documents, when taken out of context, deserves public condemnation."
What can be learned from Rush’s nightmare? Quality managers in several hospitals note that many things you may take for granted could prove to be time bombs. For example, committee meeting minutes can be devastating when taken out of context. Some advise that minutes reflect only the topics of discussion and any action taken.
A scathing comment that did not result in action or was shown to be unfounded should not be in your minutes, warns Patti Higginbotham, RN, CPHQ, director of quality improvement at Arkansas Children’s Hospital in Little Rock. "We have to be careful what and how we document incidents and where that information goes. I’d recommend that quality improvement (QI) personnel turn to their staff attorneys or risk management experts as to how to handle sensitive internal documents."
Higginbotham points to her facility’s minutes policy as one action you can take to protect yourself and your facility. "They should be lean and mean. Only write the essentials the issue, the follow-up, and the action taken."
At Arkansas Children’s Hospital, QA and QI documents are clearly marked in a way to remind employees of confidentiality. The hospital also takes tremendous pains to protect patient-identifiable data. "We have a specific plan for aggregating the data. A part of that plan is knowing who’s going to get that report, who’s responsible for analyzing it, and how we’ll report it out. We’re also starting to set up mechanisms for when to get rid of patient-identifiable documents. Once the aggregate report has gone on its way, the individual data collection tools should be shredded or otherwise destroyed."
Cost and growth focus vs. quality focus
A hospital has to search diligently and continually for quality issues and actively engage physicians in the quality discussions, according to Chris Thomson, executive director of the Heart Institute at St. Joseph’s Medical Center in Towson, MD. His interpretation on the situation at Rush is that there probably were indications that things were going awry at the Chicago hospital prior to The Wall Street Journal reporter picking up that quality document. "At this tertiary care center, we make sure things don’t reach that dimension. We work with our physicians every day and together question whether we’re maintaining our quality during the growth spurts."
"At St. Joseph’s," continues Thomson, "we have a weekly multidisciplinary forum that includes the surgeons, cardiologists, and allied health professionals. Case review, as well as trend analysis, is presented. We discuss how things are going. If there’s a concern, it’s brought up at the forum. That kind of vigilance taxes the staff involved, but it pays off in the long run. As soon as there’s an inkling that quality is being impacted, we can immediately deal with the issues related to that. We don’t wait till a problem becomes full-blown. Many hospitals are very cost-focused right now. In the long run, you have to be quality-focused. Quality will always win."
Unjudicious growth can adversely impact an overextended program. "The heart transplant field is competitive," says Thomson. "An organization has to maintain a specific volume in order to get federal funding and UNOS accreditation. But you have to strike a balance between quality and growth. You have to be vigilant during the aggressive growth cycle and diligently monitor quality indicators." And that is what Rush was trying to do with its internal quality review process, according to the hospital’s CEO.
But some experts note that complex medical issues are hard to explain in the popular press, especially emotional topics like heart transplants.
For example, while clinical reasoning can clearly justify using a heart from a smaller donor in a larger person, that reasoning is often lost on the general public. Rush officials have noted the hospital had a vigorous internal review process that had clinicians ask tough questions to make sure the hospital’s polices where sound.
Thomson was asked if issues raised in St. Joseph’s internal forums were so sensitive that case workers or physicians were afraid to discuss them. What if they got leaked to the press, as happened in Chicago?
"No. We deal with problems in an open and honest way," Thomson says. "Documentation that comes out of the forums is part of the quality process and is protected by state law."
But are those documents really protected? Even though some state laws protect quality assurance documents, leaks can happen. "All our reports are taken to a medical staff committee," says Higginbotham. Arkansas state laws that protect peer review information do so as long as it goes through the medical staff. Such laws can help keep documents from being forced into the public eye during court battles, she notes.
Be aware but wary of protections that come from your state laws. Even though quality documents when handled correctly may be protected by your state’s laws, meeting minutes or other documents can be subpoenaed during related litigation. Deborah Hare, RN, CPHQ, director of quality management and risk management at White County Medical Center in Searcy, AR, recalls being forced to turn over documents from a peer review meeting. "When they were recognized to be a part of quality assessment, they were sequestered. But we had an uncomfortable few moments."
How can you secure sensitive QA documents? "Define your process," answers Hare. "And never deviate from those steps. If your process says that a particular party is the one who keeps the peer review minutes, that person should, with no exceptions, keep the minutes."
"Also, control copies of everything. They should be numbered, and individuals should be responsible for their copy." Hare also reminds you to prepare for the worst.
If a document is leaked, the hospital should respond. "No comment" makes the public think there’s something to hide, Hare explains. If there is a real problem, the hospital should let the public know quality improvement staff will solve the problem quickly.
Secrecy is a double-edged sword. On the other side is the issue that managers shouldn’t feel constraints on what they discuss. Staff members would probably be less candid in probing hospital practices if they thought unauthorized eyes might see the questioning process.
"We have to feel free to gather data and document our findings so we’re able to look back and draw constructive conclusions. This all improves patient care," says Higginbotham.
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